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Study of BMS-986288 and Nivolumab for Patients with Advanced Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced solid cancers, which include various types such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, cutaneous melanoma, triple-negative breast cancer, renal cell carcinoma, urothelial carcinoma, and cancers of the stomach, esophagus, cervix, and colon. The study is investigating a new treatment called BMS-986288, which is being tested both on its own and in combination with another medication called Nivolumab. Additionally, the study will compare the combination of BMS-986288 and Nivolumab with a medication called Regorafenib in certain cases of colon cancer.

The purpose of this study is to understand the safety and tolerability of BMS-986288, as well as to find the best dose to use when given alone or with Nivolumab. The study will also look at how effective the combination of BMS-986288 and Nivolumab is compared to Regorafenib in treating colon cancer. Participants in the study will receive the treatments through either an injection or as tablets, depending on the medication being tested. The study will monitor participants for any side effects and how well the cancer responds to the treatment.

This trial is divided into different parts, with each part focusing on specific goals. In the initial phases, the study will focus on determining the safest dose of BMS-986288. Later phases will compare the effectiveness of the combination treatment against Regorafenib. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatments affect their cancer. The study aims to provide valuable insights into new treatment options for people with advanced solid cancers.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A biopsy may be performed to confirm the presence of advanced solid tumors, such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, or other specified cancers.

  2. Step 2

    Treatment plan discussion

    The treatment plan is discussed, including the medications involved in the study. These include BMS-986288, nivolumab, and regorafenib.

    The method of administration is explained: BMS-986288 and nivolumab are given through an intravenous infusion, while regorafenib is taken orally as a tablet.

  3. Step 3

    Treatment initiation

    The treatment begins with the administration of BMS-986288 alone or in combination with nivolumab. The dosage and frequency are determined based on the study phase and individual response.

    For some participants, regorafenib may be administered as a comparison treatment in later stages of the study.

  4. Step 4

    Regular monitoring

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests, imaging studies, and physical examinations.

    Participants are observed for any side effects or adverse reactions to the medications.

  5. Step 5

    Dose adjustment

    Based on the monitoring results, the dosage of BMS-986288 and nivolumab may be adjusted to find the most effective and safe dose.

    The goal is to determine the maximum tolerated dose and the recommended dose for future studies.

  6. Step 6

    Follow-up assessments

    Follow-up assessments are conducted to evaluate the response to treatment. This includes measuring tumor size and progression.

    The duration of response and overall survival rates are also assessed to determine the treatment's effectiveness.

  7. Step 7

    End of study participation

    At the end of the study, a final assessment is conducted to gather comprehensive data on the treatment's impact.

    Participants may receive guidance on further treatment options based on their response to the study medications.

Who can join the trial?

6 criteria

  • Must have a confirmed diagnosis of a specific type of **advanced solid tumor**. This means the cancer is in a late stage and may have spread to other parts of the body. The types of cancer include squamous cell carcinoma of the head and neck, non-small cell lung cancer, cutaneous melanoma, triple-negative breast cancer, renal cell carcinoma, urothelial carcinoma, gastric, esophageal, cervical, and colorectal cancer.
  • Must have at least one tumor that can be measured and is accessible for a **biopsy**. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined more closely.
  • Must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0 or 1. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Must have previously received at least one standard treatment for their advanced or metastatic cancer and either did not respond to it, the cancer came back, or they could not tolerate the treatment.
  • Both **male and female** participants are eligible.
  • Participants must be within the specified age range for the study.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer not listed in the study.
  • Patients who have had a severe allergic reaction to similar medications in the past.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments within a specific time frame before the study.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • BMS-986288

    is an experimental medication being tested to see how safe and tolerable it is for people with advanced cancer. Researchers are trying to find out the best dose that can be given without causing too many side effects. This medication is being studied both on its own and in combination with another drug to see how well it works against cancer.

  • Nivolumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein that usually stops the immune system from attacking cancer cells. By blocking this protein, nivolumab allows the immune system to better recognize and destroy cancer cells. In this trial, it is being used in combination with another experimental drug to see if they work better together.

  • Regorafenib

    is a medication used to treat certain types of cancer by blocking proteins that help cancer cells grow and spread. It is already approved for use in some cancers, and in this trial, it is being compared to a combination of other drugs to see which treatment is more effective for patients with a specific type of advanced cancer.

What is already known about the treatment

  • BMS-986288

    BMS-986288 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential use in treating various advanced solid tumors, including types of head and neck cancer, lung cancer, melanoma, breast cancer, kidney cancer, bladder cancer, and several others. The medication works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells more effectively. It is classified as an immunotherapy agent, which means it helps the body's immune system fight cancer.

  • Nivolumab

    Nivolumab is also administered intravenously and is a well-established medication in the treatment of several types of cancer. It is used in combination with BMS-986288 in clinical trials to enhance the immune response against cancer cells. Nivolumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby boosting the body's natural defenses. It is classified as a checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and destroy cancer cells.

Investigated diseases

  • Squamous Cell Carcinoma of the Head and Neck

    This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck. It typically begins as a small, painless lump or sore that does not heal. Over time, it can grow and invade nearby tissues, potentially causing symptoms like difficulty swallowing or changes in voice. The disease can spread to lymph nodes in the neck and, in advanced stages, to other parts of the body.

  • Non-Small Cell Lung Cancer

    This is the most common type of lung cancer, accounting for about 85% of cases. It generally starts in the tissues of the lungs and can grow slowly or rapidly, depending on the subtype. As it progresses, it may cause symptoms such as persistent cough, chest pain, and shortness of breath. The cancer can spread to other parts of the body, including the brain and bones.

  • Cutaneous Melanoma

    This is a form of skin cancer that develops in the melanocytes, the cells responsible for skin pigment. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. Melanoma can grow quickly and has the potential to spread to other parts of the body, including the lymph nodes and internal organs.

  • Triple-Negative Breast Cancer

    This is a subtype of breast cancer that lacks three common receptors known to fuel most breast cancer growth. It tends to be more aggressive and is more likely to spread and recur compared to other breast cancer types. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling.

  • Renal Cell Carcinoma

    This is the most common type of kidney cancer in adults, originating in the lining of the small tubes in the kidney. It often grows as a single mass within the kidney but can also occur in more than one part of the kidney. As it progresses, it may cause symptoms such as blood in the urine, back pain, and weight loss.

  • Urothelial Carcinoma

    This cancer begins in the urothelial cells that line the bladder and other parts of the urinary tract. It often presents with symptoms like blood in the urine and frequent urination. The disease can invade deeper layers of the bladder wall and spread to nearby organs and lymph nodes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508954-25-00Protocol codeCA043-001Estimated enrolment311 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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